A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

Abstract: Severe secondary peritonitis is diagnosed in only 20-30% of all patients, but studies to date have persisted in using a standard fixed duration of antibiotic therapy. This prospective, double-blind, multicenter, randomized clinical study compared the clinical and bacteriological efficacy and tolerability of ertapenem (1 g/day) 3 days (group I) vs >= 5 days (group II) in 111 patients with localized peritonitis (appendicitis vs non-appendicitis) of mild to moderate severity, requiring surgical intervention. In evaluable patients, the clinical response as primary efficacy outcome were assessed at the test-of-cure 2 and 4 weeks after discontinuation of antibacterial therapy. Ninety patients were evaluable. In groups I and II, 92.9 and 89.6% of patients were cured, respectively; 95.3% in group I and 93.7% in group II showed eradication. These differences were not statistically significant. The most frequent bacteria recovered were Escherichia coli and Bacteroides fragilis. A wound infection developed in seven patients (7.7%) and an intraabdominal infection in one patient (1.1%). There was a low frequency of drug-related clinical or laboratory adverse effects in both groups. Our study demonstrated that, in patients with localized community-acquired intraabdominal infection, a 3-day course of ertapenem had the same clinical and bacteriological efficacy as a standard duration.